At CLB, we have a professional regulatory affairs team with filing and submission experience in China, USA and EU. CLB provides professional regulatory consultant services as well as dossier preparation services.

Regulatory Dossier Support

• Dossier prep for IND/BLA/NDA/DMF
• Strategize meetings with regulatory authorities on documents preparation and technical advice
• Support queries and responses from regulatory authorities
• Pre and Post approval support, dossier updates, variation submissions

Regulatory Advisory

• Regulatory strategy and gap analysis for China, USA, EU and emerging markets
• Professional recommendations on an efficient regulatory pathway
• Continuous support on drug lifecycle management
• Support inspection and audits of regulatory authorities and clients

Regulatory Intelligence

• Keeping clients informed by staying abreast of regulatory updates
• Monitor the latest industry trends globally and in China
• Provide the product development strategy according to the regulatory trends
• Provide support on commercial manufacturing as per regulatory changes

For details:

• CLB Quality Overview
• CLB Quality System
• Quality Systems Model
• Integrated Digital Quality Systems
• Quality Engineering – Validation
• Quality Control
• Quality Future